The American Academy of Allergy, Asthma & Immunology (AAAAI) has published results of three Phase 1 studies of ARS Pharmaceuticals’ ARS-1 (Neffy) intranasal epinephrine that had been scheduled for presentation at the AAAAI annual meeting. The FDA granted Fast Track designation to the ARS-1 for the treatment of anaphylaxis in February 2019.
The studies, EPI 03, EPI 04, and EPI 07, all demonstrated that the epinephrine nasal spray produced equivalent exposure to injected epinephrine. ARS had previously announced positive results from the EPI 04 study.
Study author Richard Lockey of the University of South Florida, a member of the ARS scientific advisory board said, “There’s a stigma associated with needles, and fears over administrating epinephrine to oneself or someone else can cause delays in medication administration. These delays can lead to emergency situations that can put the patient in real danger. Based on these results, nasal spray epinephrine has the potential to be a needle-free alternative to intramuscular epinephrine and could help to alleviate some of those delays in treatment.”
The ARS-1 formulation includes Intravail transmucosal absortion enhancer, and Neurelis, which acquired Intravail in 2018, also issued a press release highlighting the new data. Neurelis President and CEO Craig Chambliss commented, “This endorsement by AAAAI and latest data on the ability of ARS-1 to provide injection-like absorption with a 1-mg dose of epinephrine administered intranasally provide more validation of the crucial role Intravail plays in the development of innovative products targeting areas of high unmet need. We congratulate the ARS team on their tremendous progress, which has the potential to offer people a convenient and needle-free alternative to epinephrine injection.”
Read the AAAAI press release.
Read the Neurelis press release.
